Balloon access device with features for engaging an endoscope

ABSTRACT

A balloon access device for use with an endoscope is disclosed. A transparent balloon attached to the distal end of the endoscope allows a user to both separate collapsed intestinal tissue and visualize the path of the endoscope without administering insufflation gas to the collapsed area of a patient. The attachment of the balloon to the endoscope is achieved by the various embodiments of the balloon access device disclosed herein.

RELATED APPLICATIONS

This is a continuation-in-part of U.S. patent application Ser. No.13/439,977, filed Apr. 5, 2012, which claims the benefit of U.S.Provisional Application No. 61/471,957, filed Apr. 5, 2011. Thisapplication also claims the benefit of U.S. Provisional Applications61/963,734, filed Dec. 13, 2013, and 61/997,865, filed Jun. 12, 2014.Each of these applications are incorporated by reference in theirentireties for all purposes.

TECHNICAL FIELD

The present apparatus embodied relates, in general, to medical devicesand in particular, to access balloons for use with endoscopes.

BACKGROUND

Endoscopes are well-known in the art and are flexible devices that areinserted into a natural body orifice such as the mouth or anus toprovide visual and surgical access to portions of the upper and lowergastrointestinal (GI) tract. Endoscope accessible portions of the lowerGI tract extend from the anus to the small intestine, and during thisjourney, the flexible endoscope must traverse a torturous convolutedpath through the anus, the rectum, and through the large intestine tothe ileocecal opening of the small intestine. The torturous pathincludes an “S” shaped passage through the rectosigmoid junction and thesigmoid colon, and around several larger than right angled bends of thesplenic flexure and hepatic flexure. Additionally, in small bowelenteroscopy, an endoscope must traverse a large torturous convolutedpath having multiple “S” shaped passages.

Before insertion of the endoscope, the patient is given drugs to purgefecal matter from the lower GI tract. Once emptied, the tubular walls ofthe large intestine can flatten or collapse together into a flattenedtubular configuration. The collapsed intestines may inhibit passage ofthe flat face of the distal end of the endoscope, and the collapsedtissue can inhibit visualization by pressing against or near to a cameramounted within the flat face. To enhance the passage of the endoscopethrough the collapsed lower GI tract and to improve visualization,insufflation gas is routinely pumped into the patient's lower GI tractto expand and distend the collapsed tubular tissues. The expanded wallsmay improve visualization and reduce tissue contact with the flat faceof the endoscope as it is pushed farther and farther into theinsufflated lower GI tract. The distal portion of the endoscope issteerable, and the insufflated tissue can provide room for the surgeonto visually steer the endoscope through the path ahead.

The administration of insufflation gas to the lower GI tract can induceabdominal discomfort, and this has led to the common practice ofanesthetizing the patient during the procedure. Additionally,insufflation gas may cause lengthening of anatomy and spontaneousperforation. Post-surgical recovery times are provided to allow thepatient to purge insufflation gas and to awaken from the anesthesia. CO2is commonly used for insufflation as it is more readily absorbed throughthe patient's intestinal wall to reduce the post-operative recoverytime. CO2 gas control systems, CO2 tanks, and CO2 gas heaters must bepurchased and maintained in order to provide CO2 as an insufflation gas.

SUMMARY

The present invention provides a balloon access device for use with anendoscope. The balloon access device allows a physician to both separatecollapsed tissue and visualize the path of the endoscope withoutadministering insufflation gas to the collapsed area of a patient.

In one embodiment, the balloon access device includes a balloonexpandable from a deflated shape to an inflated shape, the balloonhaving a proximal end and a distal end, wherein a dome portion is formedon the distal end of the balloon, and a cap having a proximal endconfigured to be coupled to a distal end of an endoscope and a distalend for sealing with the proximal end of the balloon when the balloon isexpanded.

In another embodiment, the inflated shape includes a non-pressurizedshape and a fully inflated shape.

In still another embodiment, the proximal end of the balloon includes aproximal collar configured to couple to a distal end of a catheter and asealing surface configured to seal with the cap.

In yet another embodiment, the cap includes an endoscope receptacleextending into the cap through the proximal end of the cap for receivingthe distal end of the endoscope.

In a further embodiment, the cap includes a stop that engages a frontface of the endoscope when the endoscope is received within the cap, andwherein an opening is provided through the stop to distally expose atleast one of a light, opening, optics or operative channel on the frontface of the endoscope.

In another embodiment, the cap includes a balloon sealing portionproximate the distal end of the cap, the balloon sealing portionincluding a circular groove that retains and seals with a circular ribof the balloon.

In still another embodiment, the cap includes an outwardly flaringballoon sealing portion that is flexible outwardly relative to a body ofthe cap to create a seal with the balloon.

In yet another embodiment, the outwardly flaring balloon sealing portionprevents the balloon from being unseated from the cap.

In a further embodiment, the cap includes a rib on an interior portionof the cap, and wherein the sealing surface of the balloon nests andseals with a receptacle of a balloon sealing portion and the rib.

In another embodiment, the dome portion is hemispherical or ellipsoidalin shape.

In still another embodiment, the balloon is non-concentrically disposedrelative to the endoscope.

In yet another embodiment, the balloon includes a distally located guidetip on a distal portion of the dome portion for guiding an operator inparting and spreading non-insufflated gastrointestinal tissue duringoperation.

In a further embodiment, the balloon is a transparent hollow balloon.

In another embodiment, the balloon access device includes a lockmechanism for securing a catheter relative to the endoscope to maintaina sealing contact between the balloon and the cap.

In still another embodiment, the lock mechanism includes a releasablylockable clamp mechanism that contacts and grips the catheter.

In yet another embodiment, the balloon access device includes a lockmechanism including a balloon insertion tube for receiving the balloonwhen the balloon is in the deflated state, the tube having a lengthgreater than a y-portion of an operative channel within the endoscope toguide the balloon into and beyond the y-portion, and a clamp forsecuring a catheter relative to the endoscope to maintain a sealingcontact between the balloon and the cap.

In a further embodiment, the balloon access device includes a ballooninsertion tube for receiving the balloon when the balloon is in thedeflated state, the balloon insertion tube having a length greater thana y-portion of an operative channel within the endoscope to guide theballoon into and beyond the y-portion.

In another embodiment, the balloon access device is in combination witha catheter, wherein the proximal end of the balloon is coupled to adistal end of the catheter.

In still another embodiment, the balloon access device is in combinationwith an endoscope, wherein the proximal end of the cap is coupled to thedistal end of the endoscope.

In yet another embodiment, the cap is integral with the endoscope.

According to another aspect of the invention, a balloon access devicefor use with an endoscope is provided. The device includes a balloonexpandable from a deflated shape to an inflated shape, the balloonhaving a proximal end and a distal end, wherein a dome portion is formedon the distal end of the balloon, a cap having a proximal end configuredto be coupled to a distal end of an endoscope and a distal end forsealing with the proximal end of the balloon when the balloon is passedthrough the cap and expanded to the inflated shape, and a ballooninsertion tube for receiving the balloon when the balloon is in thedeflated state, the balloon insertion tube having a length greater thana y-portion of an operative channel within the endoscope to guide theballoon into and beyond the y-portion.

According to still another aspect of the invention, a method of creatinga seal between a balloon and a cap is provided, the balloon having aproximal collar having a base portion and an elongated projectingportion coupled to a distal end of a catheter, and the cap having aproximal end coupled to a distal end of an endoscope, the methodincluding advancing the catheter and balloon through an operativechannel of the endoscope until the balloon is positioned distal thedistal end of the cap, expanding the balloon from a deflated shape to atleast a partially inflated shape, and moving the balloon proximallytowards the cap so that the base portion abuts a distal end of the capto create a seal between the cap and the balloon.

According to yet another aspect of the invention, a method of performinga gastrointestinal procedure on a patient having gastrointestinal tissuein a non-insufflated state using an endoscope and balloon access deviceinstalled upon the endoscope is provided, the balloon access deviceincluding a cap coupled to a distal end of the endoscope and an at leastpartially inflated balloon coupled to a distal end of a catheterreceived in an operative channel of the endoscope, the method includingadvance the endoscope through the gastrointestinal tissue, guiding theendoscope using a lens on a distal end of the endoscope and a guide tipon a distal end of the balloon, and spreading the tissue using a distaldome portion of the balloon and the guide tip, wherein the balloon istransparent so that an operator can view the tissue through the balloonusing the lens and the operator can center the guide tip in agastrointestinal tract.

In one embodiment, the method includes retracting the endoscope from thegastrointestinal tissue, wherein during the retracting a balloon sealingportion of the cap flattens a luminal fold in the tissue.

Other embodiments of the balloon access device are configured for usewith or without a cap. These embodiments are configured for use with anendoscope having an operative channel with a distal opening and avisualization channel.

Balloons for use in these embodiments are inflatable or deflatable, andhave a proximal end and a distal end having a dome portion. The proximalend may include a collar having a proximal elongated projecting portionand a base portion located distal to the projecting portion. Theprojecting portion may be configured to project proximally within theoperative channel. The proximal elongated projecting portion has acentral long axis. The size of at least two cross sections of theprojecting portion differ when taken perpendicular to the central longaxis. At least a portion of the proximal end of the balloon isconfigured for positioning over the visualization channel when theprojecting portion projects within the operative channel, such thatimaging using the endoscope visualization channel includes thetransmission of light through the proximal and distal ends of theballoon.

In some embodiments, the collar includes a shaped portion that is atleast one of pyramidal, tapered, frustoconical, or bulbous. The shapedportion may be part of the proximal elongated projecting portion of thecollar. In some embodiments, the shaped portion is adjacent to the baseportion of the collar. In other embodiments, the shaped portion isspaced from the base portion of the collar. The shaped portion may betapered. The narrower or the wider end of the taper may be positionedadjacent the base portion of the collar.

In some embodiments, the outer surface of the collar of the balloon mayinclude one or more grooves. The groove(s) may be located on theprojecting portion, the base portion, or both. The grooves may extendfrom a proximal point on the collar to a distal point on the collar. Insome embodiments, the grooves may include at least one transverse crosssection along their length, the shapes of the transverse cross sectionsincluding at least one of a polygon, a sector of a circle or ellipse,and/or a segment of a circle or ellipse. The transverse cross sectionsmay also include multiple portions, and each portion may have the shapeof a polygon, a sector of a circle or ellipse, or a segment of a circleor ellipse.

In some embodiments, the collar may include trusses. The trusses mayinclude at least one transverse cross section along their length, theshape of the transverse cross section being at least one of cylindrical,ellipsoidal and/or polygonal. The trusses may extend from at least oneproximal point on the collar to at least one distal point on the collar.They may extend along the proximal elongated projecting portion of thecollar, and they may continue distally to extend along the base portionof the collar.

In some embodiments, at least one part of the proximal collar comprisesa sun beams-shaped pattern in transverse cross section, the sunbeams-shaped pattern including multiple rays extending from a centralpoint, and multiple indentations between the rays. At least oneindentation of the sun beams pattern is configured to mate with at leastone protrusion on an underlying surface. The protrusion(s) may belocated on the distal face of the endoscope, the interior lumen of theendoscope, or both. The protrusion may be a lens in opticalcommunication with the visualization channel of the endoscope.

Methods of visualizing the internal surface of an intestinal cavity arealso disclosed. The method may include providing a balloon accessdevice, positioning a portion of the system within the intestinal cavityof the patient, moving the catheter within the operative channel of theendoscope such that at least one portion of the balloon is extendingbeyond a distal end of the endoscope, inflating the balloon, positioningthe balloon to promote contact between the base portion of the collarand a lens positioned on the distal face of the endoscope (the lensbeing in optical communication with the visualization channel of theendoscope), and maneuvering the balloon to visualize of internal surfaceof the intestinal cavity.

The method may also include assembling the system outside of a patientto promote optimal visualization through the proximal portion of theballoon during operation of the system.

Methods may include activating an optical communication systemcomprising the lens and the visualization channel of the endoscope.

Methods may include delivering fluid to the intestinal cavity throughthe operative channel of the endoscope, creating a suction between theintestinal cavity and the operative channel of the endoscope, or both.

Positioning the balloon to promote contact may include pulling thecatheter proximally to cause the base portion of the balloon to abut thelens of the endoscope.

In embodiments where at least one part of the collar of the balloonincludes a sun beams-shaped pattern in transverse cross section,maneuvering the balloon may include rotating the balloon until at leastone indentation mates with at least one protrusion on the endoscope.This protrusion may be a lens on the distal face of the endoscope.

The foregoing and other features of the invention are hereinafterdescribed in greater detail with reference to the accompanying drawings.

DESCRIPTION OF DRAWINGS

FIG. 1 is an isometric view of an embodiment of a transparent balloonaccess device deployed on an endoscope.

FIG. 2 is an isometric view of the balloon access device with thetransparent balloon shown in a normal unexpanded dome shape.

FIG. 3 is an isometric exploded view of the balloon access device

FIG. 4 is an isometric view of the balloon access device with theballoon shown collapsed by drawing a vacuum prior to being inserted intoan adjacent balloon insertion tube.

FIG. 5 is an isometric view of the balloon access device with a balloonseal cap placed on a distal end of the scope and with a dashed lineillustrating a path where the balloon access device can enter an openinstrument channel which exits within the attached balloon seal cap.

FIG. 6 is a side section view of the flexible shaft of the endoscopewith an un-inflated balloon being pushed longitudinally along aninstrument passage of the endoscope.

FIG. 7 is a side view showing the balloon after emerging from a distalend of the endoscope.

FIG. 8 is a side view showing the balloon inflated after emerging from adistal end of the endoscope.

FIG. 9 shows an exploded cross sectional view of an embodiment of theballoon and balloon seal cap.

FIG. 10 shows an exploded cross sectional view of an embodiment of theballoon and balloon seal cap.

FIG. 11 shows an exploded cross sectional view of an embodiment of theballoon and balloon seal cap.

FIG. 12 shows an exploded cross sectional view of an embodiment of theballoon and balloon seal cap.

FIG. 13 shows the balloon of FIG. 12 in a normal un-inflated shapewherein the inner air pressure is the same as the outside atmosphericpressure.

FIG. 14 shows the balloon of FIG. 12 in an inflated shape where about2.5 ml of air have been placed into the balloon and cannula.

FIG. 15 shows the balloon of FIG. 12 in an inflated shape where about3.5 ml of air have been placed into the balloon and cannula.

FIG. 16 shows the balloon of FIG. 12 in an inflated shape where about 5ml of air have been placed into the balloon and cannula.

FIG. 17 is a side cross sectional view of the balloon access deviceinstalled upon an endoscope as the balloon access device spreads tissueto burrow through non-insufflated and collapsed luminal tissue.

FIG. 18 is an enlarged side cross sectional view of the balloon accessdevice of FIG. 17 showing spreading forces on the collapsed luminaltissue.

FIG. 19 is a view through the camera lens of the endoscope showing aguide tip of the balloon moved to a centered position in a collapsedtissue lumen opening to ensure passage of the balloon and endoscope downa center of the lumen.

FIG. 20 is a cross sectional view of a blow molding dies that isconfigured to make the balloon of FIG. 12.

FIG. 21 is an isometric view of a clamp mechanism to clamp or lock thetensioned cannula relative to the endoscope to maintain a sealingcontact between balloon and seal cap.

FIG. 22 is an alternate a clamp mechanism.

FIG. 23 is a front view of a distal end of an endoscope.

FIG. 24A is a side section of an endoscope with an inflated balloon.

FIG. 24B is a side section of an endoscope with another embodiment of aninflated balloon.

FIG. 24C is a side section of an endoscope with another embodiment of aninflated balloon.

FIG. 25 is a perspective view of a balloon.

FIG. 26A is a side section of a balloon.

FIG. 26B is a tranverse section of a balloon along the section linedesignated in FIG. 26A.

FIG. 26C is a tranverse section of a balloon along the section linedesignated in FIG. 26A.

FIG. 26D is a tranverse section of a balloon along the section linedesignated in FIG. 26A.

FIG. 27 is a perspective view of a balloon including longitudinalgrooves.

FIG. 28 is a perspective view of a balloon including longitudinalgrooves and trusses.

DETAILED DESCRIPTION

The following description of certain examples of the medical apparatusshould not be used to limit the scope of the medical apparatus. Otherexamples, features, aspects, embodiments, and advantages of the medicalapparatus will become apparent to those skilled in the art from thefollowing description, which is by way of illustration, one of the bestmodes contemplated for carrying out the medical apparatus. As will berealized, the medical apparatus is capable of other different andobvious aspects, all without departing from the spirit of the medicalapparatus. Accordingly, the drawings and descriptions should be regardedas illustrative in nature and not restrictive.

It should be appreciated that any patent, publication, or otherdisclosure material, in whole or in part, that is said to beincorporated by reference herein is incorporated herein only to theextent that the incorporated material does not conflict with existingdefinitions, statements, or other disclosure material set forth in thisdisclosure. As such, and to the extent necessary, the disclosure asexplicitly set forth herein supersedes any conflicting materialincorporated herein by reference. Any material, or portion thereof, thatis said to be incorporated by reference herein, but which conflicts withexisting definitions, statements, or other disclosure material set forthherein will only be incorporated to the extent that no conflict arisesbetween that incorporated material and the existing disclosure material.

FIG. 1 is an isometric view of one embodiment of a balloon access device30 installed upon an endoscope 100. The balloon access device 30 isconfigured to fit within an operative channel 102 of the endoscope 100when undeployed, and to deploy a transparent hollow balloon 60 across adistal face 104 of the endoscope 100. The balloon 60 is transparent sothat scope optics can view GI tissue there through, and balloon 60 canbe dome shaped on at least a distal end. A distally located guide tip 62is supported solely on a distal end of the dome shape by a membrane wall65 of the balloon 60. The configuration of the deployed guide tip 62 andballoon 60 on the endoscope 100 is such that non-insufflated GI tissuecan be parted and spread with the tip 62 and the balloon 60 in responseto pushing with the endoscope 100. The balloon access device 30 andendoscope 100 as configured can rapidly burrow along a non-insufflatedand at least partially pinched GI tract such as the non-insufflatedlower GI tract, or can pass through an expanded or insufflated portionof the GI tract. As will be described in detail later, the deployedtransparent guide tip 62 can be visually aimed at a center of thecollapsed lumen of the non-insufflated GI tract by articulating a distalend 106 of the endoscope 100. When the guide tip 62 is aimed, pushingthe endoscope 100 initiates the spreading and parting of the collapsedtissue walls with the balloon access device 30, thereby enabling passageof the endoscope 100 along a center of the non-insufflated lumen of theGI tract.

As shown in FIG. 1, the balloon access device 30 is shown inserted intoan operative channel 102 of the endoscope 100 and comprises a proximalhandle portion 50 extending from a proximal opening of the operativechannel 102. A biopsy valve 108 is provided on the proximal opening ofthe operative channel 102 and a hollow catheter 70 extends from theproximal handle portion 50, through the biopsy valve 108, and into theoperative channel 102. A distal end of the catheter 70 is secured to aproximal end of the transparent balloon 60 shown extending across adistally located front face 104 of the endoscope 100.

A balloon seal cap 40 of the balloon access device 30 is removablysecured to the distal end 106 of the endoscope 100 and forms a fluidtight seal with at least one surface on a proximal end of the balloon60. Alternatively, it will be appreciated that the cap 40 may beintegral with the endoscope. The seal cap 40 may be any suitable shape,such as cylindrically shaped. The sealing interaction of the seal cap 40with the endoscope 100, and the balloon 60 with the seal cap 40, cancreate a sealed volume across the front face 104 of the endoscope 100 toprevent the egress of unwanted fluids across the optical lens 105 of anendoscope camera located on the front face 104 (see FIG. 17).Additionally, once the seal is formed, the balloon 60 can be furthersecured to the seal cap 40 by applying a vacuum to the operative channel102 to draw the balloon 60 into further engagement with the seal cap 40.Alternately, a vacuum port (not shown) in the endoscope 100 can be usedto draw the balloon 100 against the front face 104 of the endoscope. Theballoon device 30 can be rapidly deployed and inflated into place on theendoscope 100 for advancement, and rapidly deflated and withdrawn fromthe operative channel 102 of the endoscope 100 for the insertion anddeployment of another surgical instrument from the operative channel 102into the lower GI tract. An example of such another surgical instrumentcan be, but is not limited thereto, a snare or tissue biopsy device toretrieve a tissue sample from a suspect site.

FIG. 2 shows an isometric view of the balloon access device 30. Thehandle or proximal handle portion 50 includes a hollow passage 72 thatextends longitudinally through the handle portion 50, through the hollowcatheter 70, and operatively connects to an inner volume of the balloon60. Handle portion 50 includes a proximal luer lock 52 to removablyengage hollow passage 72 with compressed gas and/or vacuum lines and orfluid lines, a valve 54 to control the flow of gas and vacuum to thedistal balloon 60, a grip 56, and orientation wings 58. Hollow catheter70 can be configured to have sufficient length to work with an endoscope100 as described above, or long enough to work with a variety ofendoscopes 100 with differing lengths.

In FIGS. 2 and 3, the transparent balloon 60 is shown in the normalunpressurized or “as manufactured” shape wherein the hollow balloon 60can have a distal dome 64 and at least one sealing surface 66 on aproximal side. The balloon 60 is configured to be symmetrical andconcentric about a longitudinal axis of the balloon 60 and alongitudinal axis of the catheter 70, and the distal dome 64 can behemispherical or elliptical in shape about the axis. The balloonincludes a proximal collar 63 which includes a proximal elongatedprojecting portion 68 and a base portion 66. The proximal collar 63securely seals the balloon 60 to the catheter 70 via an attachmentmethod such as but not limited thereto, by an adhesive or a shrink fitas described later. Elongated projecting portion 68 may have a shapedportion that is cylindrical, pyramidal, tapered, or bulbous, and caninclude a conical or curved portion for engaging with or sealing withthe operative channel 102 of endoscope 100. The guide tip 62 can be aseparate piece that can be secured to the dome of the balloon 60 in theexemplary manner. As best shown in FIG. 3, the guide tip 62 has arounded distal tip and a stepped proximal post 69 that can be adhesivelysecured into a distal collar 67 formed from the balloon membrane 65.Alternately, the guide tip could be a rounded bump formed from theballoon membrane 65, or an injection of sealing material into the distalcollar 67 such as a gob of silicone placed inside the distal collar 67.The guide tip 62 can be transparent for visualization therethrough, orcan be opaque or translucent. As shown, guide tip 62 is supported byonly the balloon membrane 65 which can provide some freedom of motion ofthe tip 62 relative to the endoscope 100. This freedom of motion canbeneficial when navigating through collapsed tissue A hollow ballooninsertion tube 80 is shown distal to the guide tip 62 may be provided toreceive and store the balloon 60 and tip 62 within when the balloon isdeflated by drawing a vacuum prior to being inserted into an adjacentballoon insertion tube 80, and tube 80 can have a length sufficient toguide the balloon 60 and tip 62 into and beyond a “Y” portion of theoperative channel 102 within the endoscope 100. A deflated balloon 60 isshown in FIG. 4 just prior to insertion within a hollow of the ballooninsertion tube 80. Before insertion, balloon 60 may have one or moredeflation folds of the balloon 60 wrapped or twisted about alongitudinal axis of the balloon (not shown) to create a more compactand organized deflated balloon 60.

FIG. 5 shows the access device 30 ready for installation onto theendoscope 100. In this view, the cylindrical seal cap 40 is positionedfor placement onto the distal end 106 of the endoscope 100. The balloon60 is fully deflated as shown in FIG. 4, and resides within the ballooninsertion tube 80. A dashed line is provided to show how the ballooninsertion tube 80 of the access device 30 can be inserted into theproximal opening of the operative channel 102 of endoscope 100, and if abiopsy valve 108 is provided, through the biopsy valve 108. The ballooninsertion tube 80 can be configured to feed the balloon 60 directly intothe operative channel 102 through the balloon insertion tube 108 withthe guide tip 62 leading the collapsed balloon. Balloon insertion tube80 can be the length as shown, or can be longer to guide the collapsedballoon past a “Y” within operative channel 102 Balloon insertion tube80 can be constructed from a slick or lubricious plastic such as PTFE,or can be lubricated to reduce egress of the collapsed balloon 60 intoor out of the tube 80. FIG. 1 shows how the balloon insertion tube 80can be retracted proximally around the catheter 70 to a positionadjacent to the handle portion 50 after the full insertion of the accessdevice 30 into the operative channel 102.

FIG. 6 shows the fully deflated balloon as it is being pushed downchannel 102 of the endoscope 100 prior to emergence of the balloon 60from the distal face 40 of the endoscope 100. The guide tip 62 can beconfigured with a tip diameter that is close to the inner diameter ofthe operative channel 102 of the endoscope 100, and an appropriatelength so that the tip 62 will not cock and jam within the operativechannel 102 of the scope 100. The tip of the guide tip 62 can be anyshape that is conducive to steering the guide tip along the operativechannel 102 such as the rounded tip 62 shown, or any other guiding shapesuch as but not limited to a cone.

FIG. 7 shows the balloon 60 after emerging from the distal end 106 ofthe endoscope 100. Once the balloon 60 is extended from the endoscope 60and beyond the seal cap 40, atmospheric air may be induced through thehollow passage 72 to allow the balloon 60 to expand into thenon-pressurized shape as shown. Once the balloon 60 is fully inflatedwith a fluid, such as air, to an operating pressure or volume, theballoon 60 is pulled proximally in the direction of the arrow to engagethe balloon 60 with the seal tip 40. This pulling of the balloon 60 toseal against the seal tip 40 can be accomplished by pulling on thecatheter 70 or the handle portion 50 outside of the patient. Ifrequired, the balloon 60 is free to pivot somewhat about the attachmentpoint to the catheter 70 to center itself in the seal cap 40.

FIG. 8 shows the fully inflated balloon 60 pulled against the seal cap40 at the distal end 106 of the endoscope 100. In this view, it can beseen that the inflation of the balloon 60 has changed the at least onebase portion 66 of proximal collar 63 into a rounded dome that hasmaintained a fluid-tight seal with the seal cap 40. The rounding of theat least one base portion 66 has moved the distal dome 64 distally, andthe distal dome 64 has expanded both in diameter and longitudinally asshown. The inflation of the balloon 60 can be accomplished prior toinsertion of the endoscope 100 into the patient, or after insertion ofthe endoscope 100 into the natural orifice such as the anus of thepatient.

FIGS. 9 through 12 shows exploded cross sectional views of alternateexemplary embodiments of the balloon 60, and balloon seal cap 40 of thepresent apparatus. The guide tip 62 is also depicted. The exemplary andpreviously described embodiment of balloon 60 and seal cap 40 is bestshown in FIGS. 2, and 3, and is shown in cross section in FIG. 11. Thereader is advised to note that the balloon access device 30 is notlimited to the previously described embodiment of FIG. 11, nor to thealternate embodiments of FIGS. 9-10 and 12, nor to any of the materialsor manufacturing techniques described. Since many of the embodiments ofthe balloons and seal caps have features that perform the same function,like numbers are identified with sub-identifiers and are meant tocorrespond to like features on alternate embodiments. For example, aballoon 60 in one embodiment may become a balloon 60 a in anotheralternate embodiment. If differences in functions exist between likenumbers such as base portions 66 and 66 a, the description associatedwith the number and sub-identifier will prevail for that embodiment. Allembodiments described below have a balloon 60, 60 a. 60 b, 60 c and aseal cap 40, 40 a, 40 b, 40 c.

The embodiment of FIG. 11 comprises the hollow balloon 60, the balloonseal cap 40 and the guide tip 62. This embodiment uses a ring-in-grooveseal between the balloon and seal cap 40. The balloon 60 comprises thepreviously described distal dome 64, the membrane 65, and the at leastone base portion 66 of the proximal collar 63. With this embodiment ofthe balloon 60, the at least one base portion 66 of the ballooncomprises two distinct portions. The first portion comprises a circularrib 61 that rings the longitudinal axis of the balloon 60 and isconfigured to engage with and seal with the circular groove 41 in theseal cap 40. The second portion of the at least one base portion 66 is adish shaped portion that extends substantially radially inwardly betweenthe largest diameter of distal dome 64 to the circular rib portion. Thedish shaped portion can be configured to seal against at least adistalmost surface 48 of the cap 40. The distal collar 67 of balloon 60extends distally from the dome 64 and is configured to seal with thedistal tip 62. The elongated projecting portion 68 of the proximalcollar extends proximally from the at least one base portion 66 and isconfigured to seal with the hollow catheter 70 (see FIGS. 2 and 3).

The balloon seal cap 40 of FIG. 11 comprises a hollow cylinder having anendoscope receptacle 42 extending into a proximal end of the seal cap 40to receive and seal with the distal end 106 of the endoscope 100. Acircular rib 45 can be provided at a distal end of the endoscopereceptacle 42 to act as a stop that engages the front face 104 of theendoscope 100 once the scope 100 is fully received within the seal cap40. An opening 46 is provided through the rib 45 to distally expose theoptics, lights, and openings on the endoscope front face 104. A balloonsealing portion 44 extends distally from the rib 45 and includes thepreviously described circular groove 41 to retain and seal with thecircular rib 61 of the balloon 60. The distalmost surface 48 of theballoon sealing portion 44 can seal with the balloon 60. As shown, thereceptacle 42, the opening 46, and the balloon sealing portion 44comprise the open hollow of the cylindrical seal cap 40.

The embodiment of FIG. 9 comprises a balloon 60 a and a seal cap 40 aand is configured to provide a ball-in-socket type of sealing. Theballoon 60 a has a substantially curved base portion 66 a that nestswithin and seals with an outwardly flaring cuplike balloon sealingportion 44 a of the seal cap 40 a. Seal cap 40 a can be configured toflare outward to provide a larger support for the balloon 60 a and canexceed the diameter of the endoscope 100. Seal cap 40 a is a hollowcylinder that further comprises an endoscope sealing receptacle 42 a,circular rib 45 a, opening 46 a, as well as the previously describedballoon sealing portion 44 a. Balloon 60 a includes a distal dome 64 a,a membrane 65 a, a distal collar 67 a, and a proximal elongatedprojecting portion 68 a. Cuplike balloon sealing portion 4 a of the sealcap 40 a can also be used to flatten luminal folds, for example todiscern pathologies behind the luminal folds.

The embodiment of FIG. 10 comprises a balloon 60 b and a seal cap 40 band uses a peg-in-hole arrangement for sealing. In this embodiment, theballoon 60 b is sized to have about the same radial diameter as thedistal end 106 of the endoscope and the balloon 60 b nests and sealswith a receptacle of a cylindrical balloon sealing portion 44 a.Mushroom shaped balloon 60 a comprises a distal dome 64 with at leastone base portion 66 a that is substantially flat and circular. Balloon 6b is configured to fit snugly in the cylindrical balloon sealing portion44 a and to seal the at least one sealing surface 66 a against a rib 45b. Cylindrically shaped cap 40 b further comprises an endoscope sealingreceptacle 42 b, and an opening 46 b extending through rib 45 b. Balloon60 b includes a distal dome 64 b, a membrane 65 b, a distal collar 67 b,and an elongated projecting portion 68 b.

The embodiment of FIG. 12 comprises a balloon 60 c and seal cap 40 cthat is configured to provide a flat-to-flat seal as the balloon 60 c ispulled against a distalmost surface 48 c of seal cap 40 c. As theinflating balloon 60 c changes shape from the mushroom shape to arounded elliptical ball shape, the seal can move to a beveled portion ofa distal balloon sealing portion 44 c. Balloon 60 c may be substantiallymushroom shaped with a substantially flat at least one sealing surface66 c adjacent to a dome 64 c. Unlike the embodiment of FIG. 10, theballoon 60 c is larger than an outer diameter of a seal cap 40 c andoverhangs the seal cap 40 c. Cylindrically shaped cap 40 c furthercomprises an endoscope sealing receptacle 42 c, circular rib 45 c, andopening 46 c. Balloon 60 a further comprises a distal dome 64 a, amembrane 65 a, a distal collar 67 a, and an elongated proximalprojecting portion 68 a.

The balloons 60, 60 a, 60 b, and 60 c are transparent and can beconstructed from a substantially rigid balloon material or anelastomeric material.

Substantially rigid materials cannot expand greatly beyond the normal“as made” shape when inflated and many such materials are well known inthe art for use as expansion balloons for cardiac stent deploymentproducts. Elastomeric balloons are expandable, and can comprise materialsuch as, for example, some grades or durometers of elastomers such aspolyurethane, latex, natural rubbers, silicones and the like.

The seal caps 40, 40 a, 40 b, and 40 c can comprise a substantiallyrigid material such as a thermoform plastic, a thermoset plastic, or ametal. With rigid embodiments of the caps, it is the deformation of theballoon 60, 60 a, 60 b, and 60 c against the rigid cap that creates theseal. In yet another embodiment, the seal caps 40, 40 a, 40 b, and 40 ccan comprise an elastomeric material such as but not limited to apolyurethane, a polyethylene, silicone, rubber and the like. As such,the elastomeric properties of this embodiment can have sufficientrigidity to generally support the balloon against normal surgicaloperating forces, yet provide atraumatic characteristics, shouldsubstantial resistance be encountered. Rigidity of the elastomericmaterial could be altered by changing a durometer of the material duringmanufacturing.

Alternately, the distal balloon sealing portion 44, 44 a, 44 b, 44 c ofthe caps 40, 40 a, 40 b, and 40 c could be rigid or elastomeric and canfurther comprise one or more deformable gasket materials to create aseal such as but not limited to: an elastomeric lip seal, an o-ring, anover-molded elastomer, or a foam seal (not shown). Such seals can sealwith the balloon 40, the endoscope 100 or both.

The distal guide tip 62 can be used with any balloon embodiments such as60, 60 a, 60 b, and 60 c. The distal guide tip 62 can include thestepped proximal post 69 which is configured to fit within the distalcollar 67, 67 a, 67 b, or 67 c to create a smooth exterior when matedwith the balloon 60, 60 a, 60 b, or 60 c (see at least FIGS. 1 & 2). Theguide tip 62 and catheter 70 can be adhered to the balloon 60, 60 a, 60b, or 60 c with adhesives such as but not limited to polyurethanes orcyanoacrylates. Or, alternate fastening techniques can be used withdistal guide tip 62 and catheter 70 such as but not limited to heatstaking, ultrasonically welding, or laser welding. Whereas thesefastening techniques are described for the attachment of the distalguide tip 62, they can be used for all other embodiments of theapparatus such as elements of the handle portion 50 or attachment of theproximal collar 63 to the catheter 80.

FIGS. 13-16 are side views that detail the inflation of the distalportion of the balloon access device 30 on the endoscope 30. Themushroom shaped balloon 60 c and cap 40 c are the embodiments shown incross section in FIG. 12. For this inflation description, only theembodiment of FIG. 12 will be described, and the description is based onphysical measurements of an actual balloon 60 c and cap 40 c as theballoon 60 c is inflated.

FIG. 13 shows balloon 60 c in a normal un-inflated normal shape whereinthe inner air pressure is the same as the outside atmospheric pressureand the balloon 60 c has assumed the “as manufactured” mushroom shape.As shown, the normal shape of balloon 60 c is substantially mushroomshaped, and comprises the distal dome 64 c attached to the proximal atleast one base portion 66 c. The at least one base portion 66 c issubstantially flat and has been pulled back (via catheter 70) to sealagainst a ring of contact with the ring shaped distalmost surface 48 cof the seal cap 40. With atmospheric pressure within balloon 60 c, andthe valve 54 of the handle portion 50 closed, the balloon 62 is veryflaccid and the guide tip 62 is substantially supported by only themembrane 65 c. Pushing the guide tip 62 towards the catheter 70 createsa large indention crater with the tip 62 standing proud within as thetip 62 is completely pushed into the dome 64 c. Measurements of theballoon 60 c of FIG. 13 show an outer dimension D1 of about 18 mm at thewidest diameter, and the sum of longitudinal lengths A1 and B1 equalabout 11 mm. The balloon 60 c and catheter 70 of the actual test balloon60 c required about 2-2.1 ml of air to arrive at the flaccid shape ofFIG. 13.

FIG. 14 is another side view of the access device 30 on the endoscope100 where about 2.5 ml of air have been placed into the balloon 60 c andcatheter 70. At this air volume, the distal dome 64 c maintainedsubstantially the same shape, but the at least one base portion 66 cdomed slightly and pushed the distal dome 64 c and guide tip 62 in thedistal direction. This increased the sum of longitudinal lengths A2 andB2 to about 11.7 mm without an appreciable change in D2. It is visuallyseen that the majority of the 0.7 mm balloon longitudinal length changeoccurred in the doming of the at least one base portion 66 c whichincreased dimension B2. Pushing on the distal guide tip 62 so that it isembedded within the balloon created a slightly smaller dish shapedindent with the guide tip 62 standing proud in the indent. The increasedvolume of fill also increased the resistance to movement of the tip 62.The balloon 60 c did not appear to move longitudinally from pushing onthe guide tip 62 but expanded radially when filled with 2.5 ml of air.

FIG. 15 is another side view of the access device 30 on the endoscope100 where about 3.5 ml of air have been placed into the balloon 60 c andcatheter 70. Once again, the distal dome 64 c maintained substantiallythe same shape and the at least one base portion 66 c continued to movetowards a dome shape. The longitudinal length (sum of A3 and B3)increased to about 12.2 mm with the majority of the 0.5 mm additionallength increase coming from additional doming of the at least one baseportion 66 c. The dimension D3 increased slightly to 18.73 mm. When theguide tip 62 was pushed distally into the balloon 60 c, the distal guidetip 62 had substantial resistance. Pushing on the distal guide tip 62 sothat it is embedded within the balloon created a noticeably smaller dishshaped indent with the guide tip 62 standing proud in the indent. As theguide tip 62 was embedded into the balloon 60 c, the balloon 60 c alsomoved distally as some of the distal movement of the guide tip 62 wastransferred to the balloon 60 c. Visually, it appears that there isabout the same amount of distal longitudinal movement of the balloon 60c as there is distal embedding of the guide tip 62. The distal movementof the balloon 60 c is primarily in the at least one base portion 66 c.

FIG. 16 is another side view of the access device 30 on the endoscope100 where about 5 ml of air have been placed into the balloon 60 c andcatheter 70. The diameter D4 reduced back to the original 18 mm diameterand the longitudinal length (sum of A4 and B4) increased to about 14.75mm. Once again, the majority of the additional length increase (2.55 mm)appears to be coming from additional doming of the at least one baseportion 66 c. There was some additional rounding of the distal dome 64 cwhich may account for some of the reduction in overall diameter D4 andsome of the length change. With respect to pushing distally on the guidetip 62 with 5 ml of air, the guide tip 62 has substantial resistance andthe combination of balloon geometry (mushroom shape), fill volume (ml)balloon membrane 65 c thickness and material durometer have combined toprovide an unexpected shift in load transfer that seems to prevent theguide tip 62 from creating much of a dish indent in the balloon. Withthis fill volume, a substantial portion of the movement of the guide tip62 towards the catheter 70 comes from a longitudinal compression of theballoon 60 c to a different elliptical shape, and not from dishing theguide tip 62 into the balloon 60. This effect may be advantageous totunneling through non-insufflated tissue lumens to maintain thedistalmost positioning of the guide tip 62 during airless burrowing ofthe access device 30 and the endoscope 100. It is the distalmostposition of the guide tip 62 which can enable the guide tip 62 toinitiate separation of the collapsed luminal tissue. Once the initialseparation occurs, the collapsed tissue separation may then betransferred to the outer surface of the balloon 60 c as the accessdevice 30 and endoscope 100 advances along the GI tract.

FIGS. 17 and 18 are side cross sectional views of the balloon accessdevice 30 installed upon an endoscope 100 as it burrows throughnon-insufflated luminal tissue of the GI tract. FIG. 18 is an enlargedview of a portion of the cross sectional view of FIG. 17. As shown, theluminal tissue has collapsed, and the balloon access device 30 isproviding both a visualization pocket and a tissue separator for theoperator of the endoscope 100 so that the endoscope 100 can be easilyadvanced farther into the patient. An arrow is provided to indicate thedirection of movement of the balloon access device 30 and endoscope 100.In this cross section, the collapsed luminal tissue 200 is partiallyspread by the balloon access device 30 and endoscope 100 as it burrowstowards a bend in the tissue 200. The endoscope 100 is shown in crosssection and has the operative channel 102 and front face 104 shown.Front face 104 of the scope 100 further comprises a lens 105 that viewstissue through the transparent balloon 60. A viewing angle of the lens105 is shown as dashed lines extending from the lens 105 (see FIG. 18).To prevent reduction of the viewing angle, the cap 40 may protrude abovethe front face 104 of the scope between about 0.5 mm to about 6 mm.Alternately, the cap 40 may protrude above the front face 104 of thescope between about 1 mm to about 3 mm. If desired, the vacuum in theendoscope 100 can be used to draw the balloon 100 against the front face104 and the lens 105 of the endoscope 100. The hollow catheter 70extends longitudinally along the operative channel 102 and is attachedto the balloon 60 which is inflated (via the catheter 70) an amount thatsubstantially restricts the embedding of the guide tip 62 into theballoon as described previously. The cap 40 is sealed against theendoscope and the balloon 60 is sealed within the cap 40 to seal thefront face 104 of the endoscope 100 from fluids, mucous, and residualnatural materials normally found within the luminal structure. As shown,ring 61 of the balloon is embedded in the groove 41 in the seal cap 40to create a seal.

FIG. 18 is an enlarged side cross sectional view of FIG. 17. In thisview, the spreading of the collapsed opening 204 of the tissue 200 canbe seen through the transparent balloon 60. The lens 105 of theendoscope can be seen with dashed lines indicating a field of viewthrough the balloon access device 30. Arrows show how a spreading forceF1 is applied from the guide tip 62 onto the tissue 200. The guide forceF1 is perpendicular or normal to the point of contact on the tissue. Asecond spreading force F2 is exerted on the tissue by the inflatedballoon 60. Once again, the spreading force F2 is perpendicular ornormal to the point of contact of the membrane 65 of the balloon 60 onthe tissue.

FIG. 19 is a view through the lens 105 of the camera of the endoscope100 looking at collapsed tissue through the transparent balloon 60 andguide tip 62. In this view, the surgeon has steered the guide tip 62 ofthe balloon 60 to a centered position of the collapsed tissue opening204 of the tissue 200. Since the tissue guide 200 is transparent, tissue200 can be seen therethrough. Once the guide tip 62 of the balloon 60 iscentered, the surgeon is confident that the balloon access device 30 andendoscope 100 are aimed at the center of the collapsed lumen, and thatthe balloon access device 30 and endoscope 100 can now be pushed down acenter of the lumen such as the large intestine. During testing of thedevice in actual tissue, several of the medical professional operatorswere surprised at the depth of penetration of the balloon access device30 equipped endoscope 100 in such a short time.

FIG. 20 is a cross sectional view of a blow molding dies that isconfigured to make the balloon of FIG. 12. As shown, the blow moldingdie 210 has a piece of expandable polyethylene tubing 220 placed along alongitudinal axis of the balloon shape of the die 210. Once the tubing220 is heated, warm compressed air can be blown to expand thepolyethylene tubing 220 against the cooler inner walls of the mold 210which can be held slightly below the melting temperature of thepolyethylene tubing 220. When the flow of warm expansion air is shutoff, the tubing 220 has expanded against the walls of the mold 210 andsets in the net or normal “as manufactured” shape. Then the moldedballoon 60 can be extracted by opening the die 210 to release theballoon 60. The dashed lines show the expansion stages of thepolyethylene tubing 220 as it expands towards the mold walls 210. Thenatural tendency of the hot tubing 220 is to expand as a sphere untilthe expanding material contacts the walls of the die 210. As aconsequence, different portions of the balloon membrane 65 (see FIG. 2)will be thinner than others and may taper between the thick and thinportions. For example, the portions of the tubing 220 that form theelongated projecting portion 68 and distal collar 67 will expand not atall or very slightly and will be thicker than the balloon membrane 65 atthe points of largest expansion away from the longitudinal axis. Theshape of the balloon can affect the location of the thick and thinmembrane 65 portions and a stiffened disk may be found near theelongated projecting portion 68 and distal collars 67, which can affectthe manner in which the balloon 60 expands (see FIGS. 13-16). Thisthickening could affect or restrict the displacement of the guide tip 62from tissue contact by creating a more rigid “island” of membrane 65around the distal tip 62 that may explain the deflection behaviordescribed previously. In an alternate embodiment, the balloon 60 can befurther stiffened in local areas by a dipping process to build up theballoon wall thickness. For example, the same material as the balloonmembrane 65 can be used (such as polyurethane), or alternate dippingmaterial may be used.

With some embodiments of the balloon such as that found in FIG. 12, atension or pulling force may be applied to the catheter 70 to pull theballoon 60 c into contact with the seal cap 40 c to create a seal. Itmay be further desirable to include a lock or clamp mechanism 250 tohold the catheter 70 relative to the endoscope to ensure that the fluidtight seal is maintained in all tissue contacting situations. FIG. 21illustrates an embodiment of a clamp mechanism 250 that can be used toclamp or lock the tensioned catheter 70 relative to the endoscope 100 tomaintain a sealing contact between balloon 60 c and seal cap 40 c. Clampmechanism 250 comprises a releasably lockable clamp mechanism thatcontacts and grips catheter 70 and is actuated and released via a pullmember 252 to clamp the catheter 70. Alternate clamp mechanisms such asclamp mechanism 260 can surround the catheter 70 and retain it in placevia frictional contact. One example of clamp member 260 would be abiopsy valve 108 or an adaption thereof wherein the biopsy valve 108grips the endoscope 100 and the catheter 70 with an elastomericmaterial. And, in yet another embodiment of a clamp mechanism, theproximal balloon collar 63 may be configured to expand within theoperative channel 102 of the endoscope 100 to lock the inflated balloonto the end of the endoscope. When the balloon is deflated, the proximalcollar 63 unlocks from the operative channel 102.

FIG. 22 shows an alternate embodiment of a clamping mechanism 270 thatcould be configured to replace the previously described hollow ballooninsertion tube 80 with a clamping mechanism 270 that combines a hollowballoon insertion tube 280 with a user actuated clamp 282. The clampingmechanism 270 has a longitudinal hollow that would slide freely over thecatheter 70 and the collapsed balloon 60 c could reside within (notshown). The hollow balloon insertion tube 280 can be configured to fitwithin the operative channel 102 of the endoscope and the biopsy valve108 (if provided). The hollow balloon insertion tube 280 may be sized tobe inserted into the operative channel 102 to a position past a “Y”branch of the channel 102. The collapsed balloon 60 c can then beintroduced into the operative channel 102 of the endoscope 100 withoutdirect contact with the “Y”. Once the balloon 60 c was extended from thescope and inflated, the clamping mechanism 270 could be pushed inward tobring a stop collar 288 into contact with the proximal opening of theoperative channel, or the biopsy valve 108 (if present). Pulling on thehandle 50 or the catheter 70 while pushing on the clamping mechanism 270can ensure a seal between the balloon 60 c and the seal cap 40 c (notshown). Locking the user actuated clamp 282 ensures the seal is lockedand maintained between balloon 60 c and the seal cap 40 c. As shown inFIG. 22 but not limited thereto, the user actuated clamp 282 cancomprise a deflectable cantilever beam 284 that can, when deflected,simultaneously clamp on the catheter 70 and lock with a clamp arm 286.The clamp arm 286 can also be a cantilever, and can be deflected torelease the deflectable cantilever beam 284 to unlock the user actuatedclamp 282, and to release the catheter 70. Stop collar 288 can be usedto contact and push against the endoscope or the biopsy valve 108 tomaintain tension on the catheter 70.

Turning now to FIG. 23, a front view of the front face 104 of theendoscope is shown. The operative channel 102 of the endoscope isnon-concentrically disposed in the endoscope, and accordingly thecatheter 70 and balloon are non-concentrically disposed relative to acentral axis of the endoscope. As described previously, when the cap 40and balloon 60 are installed on the endoscope, pulling on the catheterseals the balloon 60 against the cap 40 and the non-concentricallydisposed balloon 60 is free to pivot somewhat about the attachment pointto the catheter 70 to center itself in the seal cap 40.

During operation, as the balloon 60 pushes tangentially against theintestinal wall, the force attempts to unseat the balloon from the cap.The flaring portions of the cap, shown in FIG. 9 for example, seat theballoon to prevent the seal between the balloon and the cap from beingbroken or otherwise compromised. Additionally or alternatively, the cap,for example the cap shown in FIGS. 9-12, may include one or morelongitudinal cuts in a portion of the cap protruding past the distal end106 of the endoscope to prevent the balloon from being unseated from thecap when the balloon pushes against the intestinal wall. Alternatively,the portion of the cap protruding past the distal end 106 of theendoscope may have portions of varying heights to seal with the balloon.

FIGS. 24-30 depict balloon and endoscope embodiments that are configuredfor use with or without cap 40. These balloon embodiments may optionallyhave the same or similar dimensions as balloon 60 c of FIGS. 13-16. Asdemonstrated in the cross sections of FIGS. 24A-C, the balloons 60 d, 60e, and 60 f may be positioned such that the elongated projecting portion68 of proximal collar 63 inflates to contact the operative channel 102of the endoscope. After at least partial inflation, the user may pullback on the catheter 70 to bring the base portion 66 of proximal collar63 into contact with the lens 105 (over the visualization channel 107).The transparent nature of the balloon allows for the visualization ofthe intestinal surfaces through both the proximal and distal ends of theballoon 60 d, 60 e, or 60 f. Inflation of the proximal projectingportion 68 against the wall of the operative channel 102 stabilizes theballoon to prevent it from sliding off the lens 105. This improves theclarity of the image that is transmitted to the user thoughvisualization channel 107 by preventing fluids from reaching the lens105. An illumination channel 109 and light 111 may also be included onthese or other embodiments to assist in visualization of the intestinalwall. The illumination channel and light may be covered by the baseportion 66 of the balloon in its partially or fully inflated state, suchthat the light is directed through the base portion and the distal dome64 to illuminate the intestinal wall. In FIGS. 24A-C, the operativechannel 102 is positioned around the longitudinal center of theendoscope 100. However, other embodiments may include an operativechannel that is off-center as shown in FIG. 23.

As seen in FIGS. 24A-C, the proximal collar 63 may take differentshapes. For example, balloon 60 d of FIG. 24A may have a collar with ashaped portion that is pyramidal or tapered. Balloon 60 e of FIG. 24Bmay also have a collar with a shaped portion that is pyramidal ortapered in the opposite direction as the taper of balloon 60 d. Balloon60 f of FIG. 24C may have a collar with a shaped portion that isbulbous. In some embodiments, the shaped portion is part of the proximalelongated projecting portion 68 of the proximal collar 63. For example,FIG. 24A shows a proximal collar 63 with a proximal projecting portion68 that projects into the operative channel 102 of the endoscope. Inthis embodiment, the shaped portion is tapered and located on theproximal projecting portion 68. The wider end of the taper is positionedadjacent the base portion 66 of the proximal collar 63.

Alternatively, the narrower end of the taper may be positioned adjacentthe base portion 66 as shown in FIG. 24B. In other embodiments, such asthe one shown in FIG. 24C, the shaped portion may be bulbous. Thebulbous shaped portion may be spaced from the base portion 66, as shown,or it may be positioned adjacent the base portion. FIG. 25 is aperspective view of a balloon with a tapered proximal projectingportion, similar to the embodiment of FIG. 24B. FIG. 26A is a side viewof a balloon similar to FIG. 24 B. In 26A, section lines are drawn alongthe proximal projecting portion 68. These section lines indicate thetransverse cross-sectional views shown in FIGS. 26B-D.

FIG. 27 shows an embodiment of a balloon 60 g configured for use with orwithout the cap 40. This embodiment includes a tapering shaped portion,similar to the embodiment of FIG. 25, as well as a longitudinal groove71 on the proximal collar 63. The embodiment shown has one groove, butembodiments may have multiple grooves. For example, some embodiments mayhave 2, 3, 4, 5, 6, 7, 8, 9, or 10 grooves. The grooves 71 may extendonly along the proximal projecting portion 68, or may start on theproximal projecting portion and continue along the base portion 66. Thegrooves may take various shapes when viewed in transverse cross-section.For example, the grooves 71 may be any polygonal shape, or the shape ofa segment or sector of a circle or ellipse. For example, the grooves maybe hemispherical or trapezoidal in shape. Alternatively, the grooveswhen viewed in transverse cross-section may have multiple portions, andeach portion may take the shape of a polygon or a segment or sector of acircle or ellipse. In some embodiments, grooves 71 allow the user toeject fluid around the projecting portion 68 of the proximal collar 63for assistance in cleaning the lens 105 while projecting portion 68 isinflated and abutting the walls of the operative channel 102.Alternatively, the grooves 71 may be used to activate a suction betweenthe operative channel 102 of the endoscope and the intestinalenvironment.

FIG. 28 shows an embodiment of a balloon 60 h configured for use with orwithout the cap 40. This embodiment includes a tapering shaped portion,similar to the embodiment of FIG. 25, and also includes longitudinalgrooves 71 and trusses 73. The balloon may have multiple trusses, forexample 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19,20 or more trusses. The trusses 73 may be of any shape. For example, thetrusses 73 may be cylindrical, ellipsoidal, or polygonal in shape. Thetrusses may extend from at least one proximal point to at least onedistal point on the proximal collar 63. For example, trusses 73 mayextend along only the proximal projecting portion 68, only along thebase portion 66, or along both portions 66 and 68 of collar 63. Thetrusses may act as architectural reinforcements to stabilize theballoon, keeping it in contact with the distal face of the endoscope 104and the lens 105.

The inclusion of grooves 71 or trusses 73 may give part of the proximalcollar 63 a sun beams-shaped pattern when viewed in transversecross-section (perpendicular to the longitudinal axis of the balloon).The rays of the sun beams shape are areas that thicken the wall of theballoon, such as the trusses 73 of the embodiment in FIG. 28. The sunbeams-shaped pattern includes indentations between the rays. In someembodiments, these indentations may be grooves 71, or spaces betweentrusses 73. The indentations may be configured to engage at least oneprotrusion on an underlying surface, such as the distal face 104 oroperative channel 102 of the endoscope 100. In some embodiments, theprotrusion is the lens 105. The user may position the balloon tooptimize visualization after inflation, for example by rotating theballoon such that an indentation mates with the lens 105. This allowsthe lens to image through a thinner area of the balloon wall, improvingvisualization of the intestinal structures.

While the present medical apparatus has been illustrated by descriptionof several embodiments, additional advantages and modifications mayreadily appear to those skilled in the art. For example, in someembodiments, the seal cap 40 can be configured to grip the balloon 60and the endoscope 100, thereby securing the balloon 60 to the endoscope100.

Although the invention has been shown and described with respect to acertain embodiment or embodiments, it is obvious that equivalentalterations and modifications will occur to others skilled in the artupon the reading and understanding of this specification and the annexeddrawings. In particular regard to the various functions performed by theabove described elements (components, assemblies, devices, compositions,etc.), the terms (including a reference to a “means”) used to describesuch elements are intended to correspond, unless otherwise indicated, toany element which performs the specified function of the describedelement (i.e., that is functionally equivalent), even though notstructurally equivalent to the disclosed structure which performs thefunction in the herein illustrated exemplary embodiment or embodimentsof the invention. In addition, while a particular feature of theinvention may have been described above with respect to only one or moreof several illustrated embodiments, such feature may be combined withone or more other features of the other embodiments, as may be desiredand advantageous for any given or particular application.

What is claimed is:
 1. A balloon access device for use with anendoscope, the endoscope comprising an operative channel with a distalopening and a visualization channel: a) wherein the balloon isinflatable or deflatable, and has a proximal end, and a distal endhaving a dome portion; b) wherein the proximal end of the balloonincludes a collar, the collar comprising a proximal elongated projectingportion and a base portion located distal to the projecting portion, andwherein the projecting portion is configured to project proximallywithin the operative channel; i) wherein the proximal elongatedprojecting portion has a central long axis; and ii) wherein the size ofat least two cross sections of the proximal elongated projecting portiondiffer when taken perpendicular to the central long axis; and c) whereinat least a portion of the proximal end of the balloon is configured forpositioning over the visualization channel when the projecting portionprojects within the operative channel such that imaging using theendoscope visualization channel includes the transmission of lightthrough the proximal and distal ends of the balloon.
 2. The balloonaccess device of claim 1, wherein the balloon is transparent and devoidof internal structure.
 3. The balloon access device of claim 1, whereinthe proximal end of the balloon comprises an opening that is in fluidcommunication with an interior space of the balloon.
 4. The balloonaccess device of claim 1, wherein the operative channel of the endoscopeis spaced from a longitudinal central axis of the endoscope.
 5. Theballoon access device of claim 1, wherein the collar comprises a shapedportion that is at least one of pyramidal, tapered, frustoconical, orbulbous.
 6. The balloon access device of claim 5, wherein the shapedportion is part of the proximal elongated projecting portion of thecollar.
 7. The balloon access device of claim 5, wherein the shapedportion is tapered and the narrower end of the taper is positionedadjacent the base portion of the collar.
 8. The balloon access device ofclaim 5, wherein the shaped portion is tapered and the wider end of thetaper is positioned adjacent the base portion of the collar.
 9. Theballoon access device of claim 5, wherein the shaped portion is adjacentto the base portion of the collar.
 10. The balloon access device ofclaim 5, wherein the shaped portion is spaced from the base portion ofthe collar.
 11. The balloon access device of claim 5, wherein the outersurface of the collar comprises at least one groove.
 12. The balloonaccess device of claim 11, wherein the groove is located on theprojecting portion, the base portion, or both.
 13. The balloon accessdevice of claim 11, wherein the grooves extend from a proximal point onthe collar to a distal point on the collar.
 14. The balloon accessdevice of claim 11, wherein the grooves comprise at least one transversecross section along their length, the shapes of the transverse crosssections comprising at least one of a polygon, a sector of a circle orellipse, and/or a segment of a circle or ellipse.
 15. The balloon accessdevice of claim 14, wherein the transverse cross section comprisesmultiple portions, and each portion may have the shape of a polygon, asector of a circle or ellipse, or a segment of a circle or ellipse. 16.The balloon access device of claim 1, wherein the collar furthercomprises trusses.
 17. The balloon access device of claim 16, whereinthe trusses comprise at least one transverse cross section along theirlength, the shape of the transverse cross section comprising at leastone of cylindrical, ellipsoidal and/or polygonal.
 18. The balloon accessdevice of claim 16, wherein the trusses extend from at least oneproximal point on the collar to at least one distal point on the collar.19. The balloon access device of claim 16, wherein the trusses extendalong the proximal elongated projecting portion of the collar.
 20. Theballoon access device of claim 19, wherein the trusses continue distallyto extend along the base portion of the collar.
 21. The balloon accessdevice of claim 1, wherein at least one part of the proximal collarcomprises a sun beams-shaped pattern in transverse cross section, thesun beams-shaped pattern comprising multiple rays extending from acentral point, and multiple indentations between the rays.
 22. Theballoon access device of claim 21, wherein at least one indentation ofthe sun beams pattern is configured to mate with at least one protrusionon an underlying surface.
 23. The balloon access device of claim 22,wherein the protrusion is located on at least one of the distal face ofthe endoscope and/or an interior lumen of the endoscope.
 24. The balloonaccess device of claim 23, wherein the protrusion is a lens in opticalcommunication with the visualization channel of the endoscope.
 25. Theballoon access device of claim 1, further comprising a catheterconfigured to move proximally and distally within the operative channelof the endoscope.
 26. The balloon access device of claim 25, wherein thecollar of the balloon extends over a distal end of the catheter suchthat the balloon is in fluid communication with an internal lumen of thecatheter.
 27. A method of visualizing the internal surface of anintestinal cavity, the method comprising a) providing the balloon accessdevice of claim 26, b) positioning a portion of the balloon accessdevice within the intestinal cavity of the patient, c) moving thecatheter within the operative channel of the endoscope such that atleast one portion of the balloon is extending beyond a distal end of theendoscope, d) inflating the balloon, e) positioning the balloon topromote contact between the base portion of the collar and a lenspositioned on the distal face of the endoscope, the lens being inoptical communication with the visualization channel of the endoscope,and f) maneuvering the balloon to visualize of internal surface of theintestinal cavity.
 28. The method of claim 27, further comprisingassembling the balloon access device outside of a patient to promoteoptimal visualization through the proximal portion of the balloon duringoperation of the system.
 29. The method of claim 27, further comprisingactivating an optical communication system comprising the lens and thevisualization channel of the endoscope.
 30. The method of claim 27,further comprising delivering fluid to the intestinal cavity through theoperative channel of the endoscope.
 31. The method of claim 27, furthercomprising creating a suction between the intestinal cavity and theoperative channel of the endoscope.
 32. The method of claim 27, whereinmoving the catheter within the operative channel of the endoscopecomprises pushing or pulling the catheter.
 33. The method of claim 27,wherein positioning the balloon to promote contact comprises pulling thecatheter proximally to cause the base portion of the balloon to abut thelens of the endoscope.
 34. The method of claim 27, wherein at least onepart of the collar of the balloon comprises a sun beams-shaped patternin transverse cross section, the sun beams shaped pattern comprisingmultiple rays extending from a central point and multiple indentationsbetween the rays, and wherein maneuvering the balloon to visualizecomprises rotating the balloon until at least one indentation mates withat least one protrusion on the endoscope.
 35. The method of claim 34,wherein the protrusion is the lens on the distal face of the endoscope.